BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR FEMORAL POR, RIGHT, SZ 3

    MDR report key: 20736611 · Received November 20, 2024

    Report

    Report Number
    1038671-2024-04447
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    April 6, 2018
    Report Date
    November 20, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K123687
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1038671-2023-00313 D10: CONCOMITANTS: 5242937 02-010-04-0330 - LOGIC CR FEMORAL POR, RIGHT, SZ 3, 4984788 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T, 4954612 200-02-32 - THREE PEG PATELLA 32MM, 5269011 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 4950786 201-78-82 - COLLAR FIXATION PIN 2PK 40MM. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. THE REASON FOR THE REVISION REPORTED IN (B)(4) CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FEMORAL LOOSENING. THE REPORTED PROSTHESIS WEAR AND FEMORAL LOOSENING COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 36 MONTHS AFTER A TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. THE PATIENT EXPERIENCED EMOTIONAL CHANGES AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053943 LOGIC CR FEMORAL POR, RIGHT, SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention| H SEE H11.